Core Outcome Measures in Effectiveness Trials

PERN Asthma Working Group: Developing a core outcome set and consensus statement on the conduct of RCTs for children with severe acute exacerbations of asthma.

General Information

Summary:
Acute severe childhood asthma is an infrequent, but potentially life-threatening emergency presentation. There is a wide range of different approaches to this condition, with very little supporting evidence. To improve knowledge in this area, there must first be consensus on how to conduct clinical trials, so that valid comparisons can be made between future studies.
We have formed an international working group comprising paediatricians and emergency physicians from North America, Europe, Asia, the Middle East, Africa, South America, Central America, Australasia and the United Kingdom.
We aim to develop a truly international consensus on the conduct and reporting of randomized controlled trials for children with acute severe exacerbations of asthma. This will involve the development of a shared understanding of what needs to be measured, and how it should be measured, leading to a core outcome set for research involving this group of children.

Contributors:
Simon Craig. Monash University; Monash Health; Paediatric Research in Emergency Departments International Collaborative (PREDICT). Principal investigator and PhD student.

Andis Graudins. Monash University; Monash Health; PREDICT. PhD supervisor.

Franz Babl. Emergency Department, Royal Children’s Hospital Melbourne; Murdoch Children’s Research Institute, Parkville, Victoria, Australia; Melbourne University; PREDICT. PhD supervisor

Stuart Dalziel. Starship Children’s Hospital, Auckland, New Zealand; University of Auckland, New Zealand; PREDICT

Charmaine Gray. Women's and Children's Hospital, Adelaide, South Australia; University of Adelaide; PREDICT

Javier Prego. Centro Hospitalario Pereira Rossell de Montevideo, Uruguay; Red de Investigación y Desarrollo de la Emergencia Pediátrica de Latinoamérica (RIDEPLA)

Pedro Rino. Hospital de Pediatría "Prof. Dr. Juan P. Garrahan", Buenos Aires, Argentina; Departamento de Pediatría. Universidad de Buenos Aires; RIDEPLA.

Baljit Cheema. Emergency Medical Sevices, Western Cape Health. Division of Emergency Medicine, University of Cape Town, South Africa.

Julia Höffe. University Hospital of Bern, Switzerland. Research in European Paediatric Emergency Medicine (REPEM).

Javier Benito Fernandez. Cruces Universitary Hospital; Department of Pediatrics, Basque Country University, Spain; REPEM.

Roberto Velasco. Hospital Universitario Río Hortega (Valladolid), Spain; REPEM.

Damian Roland. University Hospitals of Leicester NHS Trust; SAPPHIRE Group – Leicester University; Paediatric Emergency Research in the United Kingdom and Ireland (PERUKI).

Mark Lyttle. Emergency Department, Bristol Royal Hospital for Children, Bristol, UK; Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK; PERUKI.

Colin Powell. School of Medicine, Cardiff University, Cardiff, Wales; Noah’s Ark Children’s Hospital for Wales, Cardiff, Wales; PERUKI.

David Johnson. Alberta Children's Hospital Research Institute; University of Calgary; Pediatric Emergency Research Canada (PERC)

Suzanne Schuh. Division of Emergency Medicine, Research Institute, Hospital for Sick Children, Toronto; Department of Paediatrics, University of Toronto; PERC

Bashar Shihabuddin. Division of Pediatric Emergency Medicine, University of Oklahoma Health Sciences Center, The Children’s Hospital of Oklahoma at OUHSC; Pediatric Emergency Care Applied Research Network (PECARN)

Maria Kwok. Columbia University; New York-Presbyterian Morgan Stanley Children’s Hospital; PECARN

Prashant Mahajan. University of Michigan; Children’s Hospital of Michigan; PECARN

Robert Sapien. University of New Mexico; PECARN

Joseph Zorc. Children’s Hospital of Philadelphia; Perelman School of Medicine, University of Pennsylvania; PECARN

Michael Johnson. University of Utah; Primary Children's Hospital, Salt Lake City; PECARN.

Kajal Khanna. Stanford Emergency Department, Stanford, California; Stanford University, Stanford, California; PECARN

Indumathy Santhanam. Department of Pediatrics, Madras Medical College, Chennai, India.

Gene Ong. Department of Pediatric Emergency Medicine, Kandang Kerbau Hospital, Singapore

Thiagarajan Jaiganesh. Tawam Hospital, Abu Dhabi, UAE

Adriana Yock. Hospital Nacional de Niños ¨Dr. Carlos Saenz Herrera¨, San José, Costa Rica

Further Study Information

Current Stage:
Ongoing
Date:
March 2017 - January 2021
Funding source(s):
To be confirmed.

Health Area

Disease Category
Lungs & airways

Disease Name
Asthma

Target Population

Age Range
0 - 18

Sex
Either


Nature / type of Intervention
Any

Method(s)

Consensus meeting
Delphi process
Interview
Literature review
Survey
Systematic review

Planned projects include a systematic review of outcome measures used in RCTs of intravenous bronchodilators in children with asthma, a Cochrane overview of reviews relating to second-line therapy for acute paediatric asthma, retrospective cohort studies of children with severe acute asthma exacerbations, a review of the content and quality of current clinical guidelines for paediatric asthma, interviews with patients/families and clinicians, a systematic review of the characteristics of currently used clinical scoring systems for acute paediatric asthma, and a modified Delphi process for prioritizing outcome measures.
Additional work may include the prospective assessment of clinical scoring systems, and/or a pilot study based upon the planned consensus document


Stakeholders Involved

Clinical experts
Consumers (caregivers)
Consumers (patients)
Families
Methodologists
Patient/ support group representatives
Researchers
Service providers

Study Type

COS for clinical trials or clinical research
COS for practice

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